Pulmonary Hypertension, Quality of Life and Psychosocial Factors

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Behavioral: Evaluation of quality of life

• Registration Number: NCT01380054
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The investigators aim to :

* describe and analyse psychological characteristics, cognitive factors and representations in patients with Pulmonary Hypertension, a rare disease.

* assess the psychological characteristics impact on quality of life, check the association between disease and QoL evolution, and the variability of QoL parameters over severity class changes and follow-up

Detailed Description

PAH is a rare, and severe disease, potentially mortal, affecting preferentially young subjects. The knowledge and the international literature, as regards the quality of life, the expectations, the needs and the psychosocial characteristics of patients with PAH, are non-existent. But it is known that the persons affected by rare diseases are more vulnerable, on the psychological, social, economic and cultural planIn all the stages of the treatment, patients with PAH are confronted with heavy psychosocial situations, in a context of vital risk, with exceptional medicinal treatments (intravenous administration at home).

* QoL might be differently affected by these changes according to situational and dispositional psychological dimensions.

* the predictive role of these characteristics on the current and later quality of life, as well as the impact of diverse cognitive mediators and strategies to cope with the disease, should be investigated.The respiratory diseases department of the Montpellier hospital is regional competence center for PAH in Languedoc-Roussillon, under the aegis of the national reference center (the respiratory diseases department of Antoine Béclère hospital, Le Petit-Clamart).

Study Timeline

• Study Start: 2011-05-31
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2016-05-20
• Study Completion: 2016-05-20
• Status Verified: 2018-01
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Patients with PAH
• Patients stable since 3 months
• Patients with a severity of class I to IV
• Patients aged between 18 and 80 years
• Patients no psychological follow-up at the competence center.

Exclusion Criteria

• Patients unable to give his accordance
• Patients unable to understand the aim of the study
• Patients with recents psychiatrics disorders
• Patients with problems of understanding the tests of the study
• Drug users or drinkers
• Pregnant or women without efficacy contraception
• Patient without freedom by administration decision
• Patient in exclusion period
• Patient without french insurance
• Adult protected by the law

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with pulmonary hypertension	Evaluation of quality of life	-

Primary Outcome Measures

Name	Time	Method
Descriptive analysis of psychological characteristics on PAH patients	36 months	The descriptive analysis of psychological characteristics (anxiety, depression, social support, coping, control beliefs) is evaluated at entry and at one year. These psychological characteristics are evaluated by score of psychological questionnaires.

Secondary Outcome Measures

Name	Time	Method
Psychological characteristics impact on Quality of life	36 months	The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.
Variability of Quality of life parameters over severity class changes and follow-up	36 months	The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.
Association between disease and Quality of life evolution	36 months	The quality of life is measured by the score of the SF 36, the stage of the disease is codified by the NYHA, Qualitative and quantitative analysis of contents of the audio bands by the psychologist implicated to this study.

Trial Locations

Locations (1)

CHU; 🇫🇷 Montpellier, France